FDAHealthJuly 8, 2025

Becton, Dickinson and Company, BD Bio Sciences — BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

⚠️ Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: July 8, 2025

Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.

What's affected?

Product: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Brand: Becton, Dickinson and Company, BD Bio Sciences
Lot code: 4285713/UDI:

Additional details

Lot: 4285713/UDI: 00382906643438

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 10 kits.

View original FDA notice →

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